UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036793 |
|---|---|
| Receipt number | R000041924 |
| Scientific Title | Clinical data over long term with sitagliptin treatment for type 2 diabetes patients in our hospital |
| Date of disclosure of the study information | 2019/05/19 |
| Last modified on | 2020/01/16 08:45:02 |
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Basic information
Public title
Clinical data over long term with sitagliptin treatment for type 2 diabetes patients in our hospital
Acronym
Clinical data over long term with sitagliptin treatment for type 2 diabetes patients in our hospital
Scientific Title
Clinical data over long term with sitagliptin treatment for type 2 diabetes patients in our hospital
Scientific Title:Acronym
Clinical data over long term with sitagliptin treatment for type 2 diabetes patients in our hospital
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Administration of sitagliptin is expected not only to improve blood glucose but also to have a renal protection effect. However, there are not many reports on the long-term effects of sitagliptin in Japan.Therefore, we explore the effects on glycemic control and renal protection effect in patients with type 2 diabetes treated with sitagliptin for more than 5years.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c, Urinary albumin
Key secondary outcomes
1. Efficacy and safety of sitagliptin single use
2. Safety in the elderly
3. Safety of patients using insulin
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Outpatients
2) over 20 years old
3) T2DM
4) eGFR over 30 mL/min/1.73 m2
5) Diet and exercise therapies are well performed
6) Patients who are suspected good-compliant
7) Understanding of the study procedures and agreement to participate in the study, by giving written informed consent
Key exclusion criteria
1) Patients suspected of having secondary diabetes (ex. endocrine disease, drug-induced or liver disease)
2) Females who are pregnant or who intend to become pregnant within the study
3) Severe hepatic disease, malignancy, a history of gastrectomy and/or positive for HIV
4) Contraindication with sitagliptin
5) Patient who disqualified from the study by the investigator for any reason other than given above.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Iijima |
Organization
Tokyo Medical University
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
yasuhiro.iijima1203@gmail.com
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Iijima |
Organization
Manda Memorial Hospital
Division name
Diabetes Center
Zip code
060-0062
Address
Minami 2, Nishi 1, Chuo-ku, Sapporo
TEL
011-231-4032
Homepage URL
yasuhiro.iijima1203@gmail.com
Sponsor or person
Institute
Manda memorial hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Manda Memorial Hospital
Address
Minami 2, Nishi 1, Chuo-ku, Sapporo
Tel
011-231-4032
yasuhiro.iijima1203@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
萬田記念病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
400
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study examines the retrospective effectiveness of medical records from patients with type 2 diabetes mellitus during outpatient visits to our hospital who have been dosed with sitagliptin during 2009-2013. Evaluation items are determined on the basis of HbA1c, microalbuminuria, and progression of complications. Statistical analysis is performed on the obtained data to evaluate the effect. And we will consider the secondary effects from the following three points.
(1) Patients who continued to use sitagliptin alone, (2) elderly patients aged 65 years or older, and (3) patients with combined insulin
Management information
Registered date
| 2019 | Year | 05 | Month | 19 | Day |
Last modified on
| 2020 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041924
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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